Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers

The aim of this multi-part Phase 1 study is to evaluate the drug-drug interaction (DDI) potential of ALG-097558 via co-administration with a P-gp substrate (dabigatran) and a CYP3A4 inhibitor/P-gp inhibitor (itraconazole).

Single Dose of Broadly Neutralizing Antibody Protects Macaques from H5N1 Influenza

A single dose of a broadly neutralizing antibody given prior to virus exposure protects macaques from severe H5N1 avian influenza, NIH scientists report.

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Influenza A Viruses Adapt Shape in Response to Environmental Pressures

Influenza A virus particles strategically adapt their shape – to become either spheres or larger filaments – to favor their ability to infect cells depending on environmental conditions, a new NIAID study published in Nature Microbiology reveals. This previously unrecognized response could help explain how influenza A and other viruses persist in populations, evade immune responses, and acquire adaptive mutations. The scientists designed the study to determine why many influenza A virus particles exist as filaments, which requires more energy to form than a sphere.

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NIH Officials Assess Threat of H5N1

HPAI H5N1 influenza remains a low risk to most Americans, but that does not diminish concern about the virus, NIAID experts say.

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Single Mutation in H5N1 Influenza Surface Protein Could Enable Easier Human Infection

A single modification in the protein found on the surface of the highly pathogenic avian influenza (HPAI) H5N1 influenza virus currently circulating in U.S. dairy cows could allow for easier transmission among humans, according to new research funded by the National Institutes of Health (NIH) and published today in the journal Science. The study results reinforce the need for continued, vigilant surveillance and monitoring of HPAI H5N1 for potential genetic changes that could make the virus more transmissible in humans.

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First Webinar of Long COVID Treatment Initiative Highlights Early Progress

NIAID Now |

By Jeanne M. Marrazzo, M.D., M.P.H., Director, NIAID, and Julie L. Gerberding, M.D., M.P.H., CEO, Foundation for the National Institutes of Health (FNIH)

On Nov. 21, NIAID and the Foundation for the National Institutes of Health (FNIH) launched its first in a series of online webinars highlighting recent progress in the new Researching COVID to Enhance Recovery - Treating Long COVID (RECOVER-TLC) program. More than 800 patients, advocates, care providers, and scientists from academia and life sciences companies were on hand for the inaugural webinar. Those unable to attend the webinar can access the recording here.

The purpose of this webinar series is to provide brief updates on the progress of RECOVER-TLC, review recent Long COVID-related scientific advances, and offer a forum for asking questions and sharing concerns, ideas, and comments. During the Nov. webinar, Joe Breen, Ph.D., chief of NIAID’s Immunoregulation Section in the Division of Allergy, Immunology and Transplantation, highlighted recent RECOVER-TLC activities that have occurred since the program’s scientific workshop in September, including:

  • Establishment of a new Web-based portal for submitting suggested therapeutics and biologics for potential clinical testing in RECOVER-TLC;
  • Development of an intervention prioritization process and establishment of specialized working groups, including members with relevant expertise, to prioritize these submissions; and
  • NIAID’s issuance of a Request for Information (RFI) seeking: input on potential Long COVID therapeutics; working group involvement from patients, health care providers, scientists and clinicians; suggestions for potential biomarkers/endpoints for future RECOVER-TLC clinical trials and general feedback about the RECOVER-TLC initiative. The RFI is open for comment until Feb. 1, 2025.

Elizabeth Geerling, Ph.D., FNIH Associate Project Manager, Translational Science reported during the webinar that to date, there have been more than 300 submissions to the RECOVER-TLC interventions portal, including potential drugs, therapeutic agents, biologics, nutrition and dietary agents, and other intervention types. More than 70% of these submissions came from patients and providers with the remainder from researchers and biopharmaceutical companies. We were glad that Webinar participants took advantage of the question-and-answer session to offer comments, concerns and ideas for RECOVER-TLC. Your input is vital to the success of the program.

In December, NIAID, along with the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Neurological Disorders and Stroke (NINDS), will announce 20 new awards to fund RECOVER pathobiology projects. Critical findings from these projects will inform the RECOVER-TLC treatment studies. Additionally, next month, NIAID and FNIH will begin distributing an online monthly newsletter sharing the latest RECOVER-TLC activities.

We expect to host the next RECOVER-TLC webinar in early January 2025. Until then, please continue to use the links in the RFI to share suggestions for potential agents for testing, volunteer to participate in our working groups, and provide us with general feedback on the RECOVER-TLC program.

Thank you in advance for your interest in this critical health condition as we move forward to achieve our collective goal of rapidly bringing safe and effective treatments to all those affected by Long COVID.

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UGA Partners with FDA to Test U.S. Dairy Supplies for Avian Influenza